PIEB versus CEI for epidural labor pain relief
Comparison of Continuous Epidural Infusion vs. Programmed Intermittent Epidural Bolus Combined With Patient-Controlled Epidural Analgesia for Labor Pain Relief: A Randomized Controlled Trial
This trial will test whether programmed intermittent epidural boluses (PIEB) or a continuous epidural infusion (CEI), each combined with patient-controlled epidural analgesia (PCEA), works better for pain relief during labor in women having vaginal delivery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Da Nang Family General Hospital Academic / other |
| Locations | 1 site (Da Nang) |
| Trial ID | NCT07395934 on ClinicalTrials.gov |
What this trial studies
This prospective, randomized controlled trial at Family General Hospital, Da Nang will randomize 60 term parturients to receive either PIEB or CEI maintenance after a standardized initial epidural bolus of 10 mL 0.1% ropivacaine with 2 mcg/mL fentanyl. The PIEB arm receives automated 8 mL boluses every 60 minutes starting one hour after induction, while the CEI arm receives a continuous infusion of 8 mL/hour; both arms have access to PCEA delivering 5 mL boluses with a 10‑minute lockout and a 20 mL/hour limit. Rescue analgesia is provided by a 5 mL manual bolus if pain (VAS) remains greater than 4 after two consecutive PCEA demands. Primary outcomes include VAS pain scores, total anesthetic consumption, maternal satisfaction, and neonatal Apgar scores to compare analgesic quality, drug use, and motor preservation.
Who should consider this trial
Good fit: Ideal candidates are healthy term pregnant women aged 18–40 (ASA II) with singleton vertex pregnancies in active labor planning vaginal delivery and no contraindications to epidural anesthesia.
Not a fit: Women with contraindications to epidural anesthesia, allergy to ropivacaine or fentanyl, high‑risk pregnancies (e.g., preeclampsia, placenta previa), fetal distress, or who require immediate cesarean delivery are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the PIEB approach could provide better pain relief with lower local anesthetic use and better preservation of maternal motor function compared with continuous infusion.
How similar studies have performed: Prior randomized studies have shown PIEB can reduce local anesthetic consumption and sometimes improve analgesia compared with CEI in labor, though results vary between settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parturients indicated for labor analgesia for vaginal delivery via epidural anesthesia. * Age from 18 to 40 years. * Physical status: ASA II. * Singleton pregnancy, full-term, vertex presentation in labor. * Indication for vaginal delivery. * No contraindications to epidural anesthesia. * Agreement to participate in the research and signed written informed consent. Exclusion Criteria: * Contraindications to epidural analgesia. * History of allergy to local anesthetics (Ropivacaine) or opioids (Fentanyl). * High-risk pregnancies: Preeclampsia, placenta previa, placental abruption. * Fetal distress or fetal abnormalities. * Chronic use of analgesic drugs or neurological/psychiatric disorders. * Parturients who refuse to participate or request to withdraw from the research.
Where this trial is running
Da Nang
- Family General Hospital — Da Nang, Vietnam (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.